The FDA's notes from its visit to Theranos' labs don't look good

Theranos, a $10 billion company that says its blood tests can be
done accurately with a single drop of blood, has come under fire
after a
lengthy Wall Street Journal exposé questioned just how
revolutionary the startup was.

The reports are Form 483s, which are issued at
the end of inspections when investigators see anything that
may violate the Food Drug and Cosmetics Act. They are from an FDA
visit that took place between August 25 and September 16, and
they are heavily redacted. Nevertheless, they are worrisome.

The FDA claims the containers Theranos has been using to collect
blood, known as nanotainers, never got regulatory approval: "You
are currently shipping this uncleared medical device in
interstate commerce, between California, Arizona, and
Pennsylvania."

Here are some of the other main observations sent to Theranos CEO
Elizabeth Holmes and president/COO Ramesh "Sunny" Balwani.

Here, the FDA digs into Theranos' use of TSCDs, or Terumo sterile
tubing welders, used in the lab as part of blood testing.

Observation 4: "Results of the design risk analysis were
not adequately documented."

FDA

Documentation seemed to be a key sticking point for the FDA
inspectors.

Observation 5: "Documents were not reviewed and not
approved by designated individual(s) prior to
issuance."FDA

It appears as if this isn't the first time Theranos has butted
heads with FDA inspectors: "This document was provided as a
follow-up to the failures in your design validation conducted in
2014," the FDA report says.